FDA Gets Up to Make New GRAS Rule, then Climbs Back into Bed with Big Food

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“The Food and Drug Administration published a new rule last week to clarify how it regulates ingredients that are added to processed food that are generally recognized as safe…

...some say the 329-page rule on these additive ingredients — known by the acronym GRAS…brings more obfuscation than understanding. The rule adds more detail to how a report needs to be made, but does not fundamentally change the hands-off process the agency has used to approve these ingredients since 1997.

Consumer groups say that the rule allows manufacturers to continue to hide their actions and secretly add things that may be unsafe to food.”

Not surprisingly, it appears that Big Food and Big Chemical’s regulatory capture of the FDA continues on as usual.* If you are unfamiliar with why clean food advocates find this latest FDA move so egregious, here is a brief overview of the backstory from our position paper on the topic:

“Numerous studies and reports recently released by nonprofit consumer advocacy organizations and reporting agencies indicate that a disturbing number of new additives (“ingredients”) have been dumped into the U.S. food supply by the processed food industry using a loophole in the GRAS approval system—chemical ingredients that the FDA has not registered and not independently approved as safe…

For the past 15 years the U.S. Food and Drug Administration (FDA) has looked the other way while Big Food corporations have used a giant loophole in the GRAS system (the food additive/ingredient approval system known as “Generally Recognized as Safe”)to dump numerous synthetic and industrialized food additives into the food supply sans the mandated safety testing to assure that the additives are safe for humans (including in utero, infants and children) and that they have no significant short-term adverse effects or potential for long-term health complications.

“Currently, companies may determine a substance is “Generally Recognized as Safe” (GRAS) without FDA’s approval or knowledge…a few substances previously considered GRAS have later been banned; and concerns have been raised about the safety of other GRAS substances…

GAO recommends that FDA take steps to better ensure the safety of GRAS substances, including developing a strategy to require any company that conducts a GRAS determination to provide FDA with basic information about it.”

-U.S. Government Accountability Office (GAO)

Over the past decade and a half and counting systemic problems with governmental agencies charged with the task of overseeing food safety have continued, and in some cases have worsened. In a classic case of the fox guarding the hen house, a recent study conducted by the Pew Research Center and published in a prestigious American Medical Association (AMA) journal reported that a large percentage of food additives have never been reviewed or safety tested by the U.S. Food and Drug Administration (FDA) and in fact, the food manufacturers themselves have been the ones determining what additives are safe enough to inject in the public food supply.

“Because of the apparent frequency with which companies make [their own] GRAS safety determinations without telling the FDA…

We were able to identify 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations…Companies found their chemicals safe for use in food despite potentially serious allergic reactions, interactions with common drugs, or proposed uses much greater than company-established safe doses.

~Generally Recognized as Secret: Chemicals Added to Food in the United States. National Resources Defense Council (NRDC) Report

According to the Pew study and the National Resource Defense Council report, the majority of food additives (“ingredients”) added to processed foods through the GRAS system in recent years are unknown even to the FDA and have not been scientifically safety tested, the adverse effects of processed food overall have. This is particularly troubling given that a number of scientific studies have linked additive-laden processed foods with a range of health problems including obesity, diabetes, depression, lethargy, cognition problems, increased incidence of tumors, heart and kidney problems, autoimmune disorders, and endocrine/hormonal problems, to name a few.”

Aside: For some additive-filled icing on the processed cake, according to the journalist’s account of this story, Dr. Leon Bruner, chief science officer for the Grocery Manufacturers Association, stated, ‘all food products have every ingredient on their labels, so nothing can be secretly added.’ Either Dr. Bruner is completely out of the loop about industry norms, or he is willfully trying to uphold the long-standing murky reputation of the GMA. If it was the latter, he was successful.

Also see this editorial on the topic written by Tom Neltner, the man behind the impressively comprehensive Pew Foundation research project on food additives which revealed that with the FDA’s approval, Big Food has been secretly dumping additives into U.S. processed foods sans the required safety testing for human consumption, and oftentimes without even notifying the FDA.

Here’s a shocking fact about your food: A company can decide for itself that a chemical is safe to use in food and doesn’t have to tell the Food and Drug Administration, the agency charged with protecting our food supply. If that same chemical was used to make a tennis racket, the company would have to notify the Environmental Protection Agency, giving the EPA the opportunity to review it for safety…

Food companies use additives to flavor food, enhance its color, prevent spoilage, and more. It includes chemicals used in packaging and food processing equipment that may get into food and covers more than just the ingredients listed on the label. Of the 10,000 or so additives, about 1,000 have been deemed by companies in secret to be generally recognized as safe…

[The recent FDA ruling on GRAS (those food additives determined to be generally recognized as safe)] lets a company continue deciding if something is GRAS based on the professional judgment of one of its own employees using data that would “ordinarily be published” but may, in fact, be secret. The agency did not restrict the obvious conflicts of interest, promising to issue nonbinding guidance to help companies select who is qualified to decide whether a chemical is safe to use in the food we feed our families.